Collecting Bag 2000ml (Straub Medical®)

The collecting bag is non-patient contacting and is attached to the silicon outflow tube on the proximal end of the catheter. The fluid aspirated by the catheter passes through the…

Registry build 21.09.26

The collecting bag is non-patient contacting and is attached to the silicon outflow tube on the proximal end of the catheter. The fluid aspirated by the catheter passes through the catheters’ outflow tubing into the Collecting bag.

51manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Jiangsu (25), Zhejiang (9), Shanghai (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KNX
Manufacturer City Province Registered as Device types
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Sino Protection (Hefei) Medical Products Co., Ltd. Hefei Anhui Contract manufacturer 18
Hitec Medical Co., Ltd. Shanghai Shanghai Contract manufacturer 17
Forefront Medical Technology (Jiangsu) Co., Ltd. Changzhou Jiangsu Contract manufacturer 14
Heyuan Hong DE Medical Products Co., Ltd. Heyuan Guangdong Contract manufacturer 13
Meifu Medical Technology Suzhou Co., Ltd. Suzhou Jiangsu Contract manufacturer 13
Primecare Medical (Huzhou) Co., Ltd. Hu Zhou Zhejiang Contract manufacturer 9
Anhui Careplus Medical Technology Co., Ltd. Xuancheng Anhui Contract manufacturer 6
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129

Showing 12 of 51. All 51 manufacturers in China registered for Collector, Urine, (And Accessories) For Indwelling Catheter

Record

Regulatory record for Collecting Bag 2000ml (Straub Medical®)
Listed by Straub Medical AG, Switzerland
FDA product code KNX
Device type Collector, Urine, (And Accessories) For Indwelling Catheter
Device class Class 2
Regulation 21 CFR 876.5250
Establishment Manufacturer
510(k) K172315
Record published 2020-01-31
Record revised 2025-09-22 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Sizes Total volume 2000 ml
Distribution end date 2025-01-28

Catalogue Numbers

Catalogue numbers for Collecting Bag 2000ml (Straub Medical®)
Catalogue number Size Status
Version 1.0 Total Volume 2000 ml Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dover Cardinal Health 71
Urine Bag Well Lead Medical Co., Ltd. 64
Dover Cardinal Health 200, LLC 53
Medline Medline Industries, Inc. 19
Rusch Teleflex Medical LLC 10
Bard® Urine Meter with Bag C.R. Bard, Inc. 10
Bard® Add-A-Foley Tray C.R. Bard, Inc. 10
AMSure® Urinary Drainage Bag Amsino Medical Inc. 8
Bard® Urinary Drainage Bag with Anti-Reflux Chamber C.R. Bard, Inc. 6
Bard® Urinary Drainage Bag C.R. Bard, Inc. 6
Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) Urocare Products, Inc. 6
Medline Industries, Inc. Medline Industries, Inc. 5

Showing 12 of 113. All products under Collector, Urine, (And Accessories) For Indwelling Catheter

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer